Regulation FD Disclosure (Form 8-K)

On September 15, 2025, BioXcel Therapeutics, Inc. (the "Company") provided the following corporate and financing updates:

Clinical Trial Update

On September 13, 2025, the Company completed enrollment in its open label clinical study designed to evaluate the correlation between the patient-and informant-reported mCGI-S measurement and the Positive and Negative Syndrome Scale-Excitatory Component ("PEC") scale, conducted by trained raters. The study was designed to evaluate approximately 30 patients and the Company expects to release the results in the fourth quarter of 2025.

The results from this study, along with the results of the SERENITY At-Home Pivotal Phase 3 Safety Trial already announced, will be included in the clinical package for the sNDA submission, which is expected in the first quarter of 2026.

Financing and Liquidity Update

On April 3, 2025, the Company entered into an Equity Distribution Agreement with Canaccord Genuity LLC to sell shares of Common Stock through any method permitted that is deemed an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, under which Canaccord Genuity LLC will act as sales agent (the "ATM Program"). The Company filed a prospectus supplement with the Securities and Exchange Commission on April 3, 2025, in connection with the offer and sale of up to $8.1 million shares pursuant to the ATM Program (the "April ATM Prospectus Supplement"). On August 6, 2025, the Company filed a further prospectus supplement with the Securities and Exchange Commission in connection with the offer and sale of an additional $3.5 million shares pursuant to the ATM Program (the "August ATM Prospectus Supplement"). As of August 18, 2025, the Company filed a further prospectus supplement with the Securities and Exchange Commission in connection with the offer and sale of an additional $80.0 million shares pursuant to the ATM Program (the "Second August ATM Prospectus Supplement").

Between July 1, 2025 and September 15, 2025, the Company raised an aggregate of $37.3 million, including (i) aggregate gross proceeds of approximately $27.6 million pursuant to the sale of 9,312,892 shares under the ATM Program and (ii) aggregate gross proceeds of approximately $9.7 million pursuant to the exercise of outstanding warrants to purchase a total of 2,300,000 shares. As of September 12, 2025, the Company had a total of 19,646,801 shares outstanding.

As a result of the receipt of these proceeds, the Company believes that their existing cash and cash equivalents will be sufficient to enable them to fund operating expenses and capital expenditure requirements into the first quarter of 2026. The Company has based this estimate on assumptions that may prove to be incorrect, and the Company could utilize available capital resources sooner than expected. The amounts and timing of actual expenditures will depend on numerous factors, including the progress of clinical and regulatory development efforts and other factors described under "Risk Factors" in the Company's SEC filing that are incorporated by reference herein, as well as the amount of cash used in our operations.

The disclosure under Item 7.01 is included in this Item 8.01 of this Current Report on Form 8-K and incorporated herein by reference, other than the sixth paragraph.